A team of British scientists have launched a clinical trial to evaluate an antiviral drug to treat monkeypox, the first study of its kind as experts mobilize to contain the global outbreak and gather vital real-world information on how available drugs and vaccines fare against the disease.
The trial, dubbed Platinum, will investigate whether SIGA Technologies’ tecovirimat is a safe and effective treatment for monkeypox.
Tecovirimat, also known as Tpoxx, is an antiviral treatment originally developed for smallpox, a similar virus.
The drug is already available for some monkeypox patients based on trials in animals and healthy humans but it is not proven as an effective treatment.
Platinum will assess whether tecovirimat helps patients recover from monkeypox faster—including the rate at which lesions heal and the time taken for people to test negative for the virus—as well as its ability to keep patients out of hospital.
The U.K. government-funded study, run by the team spearheading one of the major Covid treatment trials, aims to enroll at least 500 people with monkeypox from across the country who will receive either a placebo or tecovirimat to take twice a day for two weeks at home.
Study co-leader Sir Peter Horby, a professor of emerging infections and global health at Oxford University, said early data on tecovirimat are “promising” but only randomized clinical trials like Platinum will provide the kind of evidence needed to “treat patients with confidence.”
Specific treatments and vaccines for use against monkeypox are scarce despite having been known and circulated in parts of Africa for decades. The monkeypox virus is a close relative of variola, which causes smallpox and has been eradicated, and experts believe treatments and vaccines designed for smallpox will work against monkeypox. Lab studies and trials in animals and healthy humans—for vaccines scientists tested the immune response generated rather than ability to prevent disease—suggest this may be the case but there is no strong data proving real-world effectiveness. No treatments have been proven to work against monkeypox and just one vaccine has been specifically approved for use against monkeypox in the world, though strong evidence that it works is also lacking. The shot—marketed as Jynneos in the U.S., Imvanex in Europe and Imvanune in Canada—is produced by just one company, Danish biotech Bavarian Nordic, and is in critically short supply. The U.S. is trialing a dose-stretching strategy officials believe could quintuple the number of doses available without affecting efficacy.
42,954. That’s how many confirmed cases of monkeypox there have been around the world during this year’s outbreak, according to the Centers for Disease Control and Prevention. There have been 12 confirmed deaths, five in locations that have not historically reported monkeypox. The majority of confirmed cases have been reported in the U.S., where there have been more than 15,400 cases. No monkeypox deaths have been reported in the U.S. Data strongly suggests transmission of the virus is being driven by sex between men, a departure from previous beliefs that just skin-to-skin contact, which obviously accompanies sex, was fueling the outbreak.
Life Sciences, Forbes – Healthcare